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Trial registered on ANZCTR
Registration number
ACTRN12607000583448
Ethics application status
Approved
Date submitted
7/09/2007
Date registered
14/11/2007
Date last updated
2/03/2012
Type of registration
Retrospectively registered
Titles & IDs
Public title
Pulmonary rehabilitation or self management for Chronic Obstructive Pulmonary Disease: What is the best management approach?
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Scientific title
Pumonary Rehabilitation or Chronic Disease Self Managment for Chronic Obstructive Pulmonary Disease to improve Disease Specific Health-Related Quality-of-Life
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Universal Trial Number (UTN)
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Trial acronym
PRSM
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease
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Condition category
Condition code
Respiratory
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0
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Chronic obstructive pulmonary disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Pulmonary Rehabilitation: 8 weeks of upper and lower limb strengthening plus cardiovascular exercise under direct physiotherapist supervision for 2 x 1hour sessions per week, plus one 2 hour education session per week.
Chronic Disease Self Management (CDSM): Stanford CDSM: 17 hours of instruction once weekly over 7 weeks incorporating skills mastery, reinterpretation of symptoms, modeling, and social persuasion to enhance a sense of person efficacy.
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Intervention code [1]
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Rehabilitation
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Comparator / control treatment
Usual care through general medical practitioner
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Control group
Active
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Outcomes
Primary outcome [1]
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St George's Respiratory Questionnaire.
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Assessment method [1]
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Timepoint [1]
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0, 3, 6, 9 and 12 months
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Secondary outcome [1]
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Frenchay Activities Index
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Assessment method [1]
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Timepoint [1]
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0.3.6.9 and 12 months
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Secondary outcome [2]
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International Physical Activity Questionnaire
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Assessment method [2]
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Timepoint [2]
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0.3.6.9 and 12 months
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Secondary outcome [3]
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Hospital Anxiety and Depression Scale
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Assessment method [3]
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Timepoint [3]
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0.3.6.9 and 12 months
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Secondary outcome [4]
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Chronic Obstructive Pulmonary Disease Self-efficacy Scale
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Assessment method [4]
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Timepoint [4]
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0.3.6.9 and 12 months
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Eligibility
Key inclusion criteria
chronic obstructive pulmonary disease
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Unstable cardiac disease
2. Recent (<3 months) neurological injury (eg. stroke)
3. Musculoskeletal conditions that prevent participation in exercise sessions
4. Limited written and verbal English language skills
5. Unstable psychiatric comorbidity precluding participation in group intervention sessions
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Concealed allocation via central randomization by phone or computer administered from an 'off-site' location
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization by using a randomization table created by computer software
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
28/09/2007
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
318
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment postcode(s) [1]
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4000
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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MBF Foundation Ltd
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Address [1]
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MBF Foundation
Level 18, 50 Bridge Street
SYDNEY NSW 2000
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Country [1]
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Australia
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Primary sponsor type
University
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Name
The University of Queensland
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Address
The University of Queensland, Qld, 4072
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Country
Australia
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Secondary sponsor category [1]
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Charities/Societies/Foundations
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Name [1]
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MBF Foundation Ltd
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Address [1]
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MBF Foundation
Level 18, 50 Bridge Street
SYDNEY NSW 2000
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Country [1]
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Medical Research Ethics Committee
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Ethics committee address [1]
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Ethics Officer The University of Queensland, 4072
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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27/08/2007
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Approval date [1]
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Ethics approval number [1]
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2007001205
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Ethics committee name [2]
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Ethics committee address [2]
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Ethics committee country [2]
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Date submitted for ethics approval [2]
4707
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Approval date [2]
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31/10/2007
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Ethics approval number [2]
4707
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2007001205
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Summary
Brief summary
This project will examine three approaches to the management of chronic obstructive pulmonary disease. It will evaluate whether any of the approaches are superior in terms of better outcomes and also which one is most economical relative to its benefits. The three approaches are a self-management approach, a structured respiratory rehabilitation program and standard general medical practice management.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Prof Bill Vicenzino
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Address
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Division of Physiotherapy
The University of Queensland
St Lucia Campus, 4072
Qld
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Country
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Australia
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Phone
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3365 2275
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Fax
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3365 1622
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Email
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b.vicenzino@uq.edu.au
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Contact person for scientific queries
Name
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Prof Bill Vicenzino
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Address
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Division of Physiotherapy
The University of Queensland
St Lucia Campus, 4072
Qld
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Country
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Australia
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Phone
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3365 2275
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Fax
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3365 1622
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Email
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b.vicenzino@uq.edu.au
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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